NCT01326559已完成2 期
Phase II Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil Followed by Weekly Docetaxel and Cetuximab in Concurrence With Intensity-modulated Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma (NPC)
Hong Kong Nasopharyngeal Cancer Study Group Limited4 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Complete response rate
研究概览
简要总结
Study Objective:
Primary
- To evaluate the complete response (CR) rate with induction chemotherapy using Docetaxel, Cisplatin and Fluorouracil(TPF) followed by Docetaxel plus Cetuximab (TC) in concurrence with intensity-modulated radiotherapy (IMRT).
Secondary
- To determine the overall response rate.
- To determine the locoregional and distant control rate
- To determine the progression-free survival (PFS)
- To determine the overall survival (OS)
- To determine the safety of the induction chemotherapy and concurrent chemoradiation plus Cetuximab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Use of investigational agent within the past 28 days
- •Pre-treatment with an anti-EGFR drug
- •Severe cardiac disease such as heart failure, coronary artery disease or myocardial infarction within the last 12 months
- •History of severe pulmonary diseases
- •Active infection or other systemic disease under poor control
- •Uncontrolled chronic neuropathy
- •Know grade 3 or 4 allergic reaction to any of the components of the treatment
- •Estimated life expectancy is less than 3 months
- •Pregnancy or breast feeding
研究组 & 干预措施
Experimental 1
Experimental
Induction chemotherapy using Docetaxel, Cisplatin and 5-FU for week 1 to week 9 and followed by concurrent chemoradiation plus cetuximab from week 10 to week 16
干预措施: Docetaxel, Cisplatin, 5-FU and Cetuximab (Drug)
结局指标
主要结局
Complete response rate
时间窗: 5 years
Complete response rate is defined as the proportion of subjects with disappearance of all target lesions after induction and concurrent therapies.
次要结局
- Overall response rate(5 years)
- Locoregional and distant control rate(5 years)
- Progression free survival(5 years)
- Overall survival(5 years)
研究者
Dr. ANNE W M LEE
Chief of Service, Dept of Clinical Oncology, PYNEH
Hong Kong Nasopharyngeal Cancer Study Group Limited
研究点 (4)
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